Regulatory Affairs Associate

About the company

Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders.

About the role

The Regulatory Affairs Associate will support the Regulatory Team in:

• Preparation and submission of marketing authorisation applications in global markets, including USA and Australasia;
• Obtain regulatory approvals globally for designated product portfolio;
• Manage national regulatory commitments and submissions;
• Manage orphan drug designations for US and Australasia;
• Manage clinical trial applications in US and Australasia; and
• General regulatory advice to management for designated product portfolio.

Knowledge and skills:

• Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplines;
• Working knowledge of international regulatory standards in the areas of quality and safety;
• Must have experience with prescription medicine; and
• Experience with NDA/ANDA applications and applications to TGA.

The perks:

• WFH 2 days a week;
• Annual bonus; and
• Work alongside world-leading regulatory experts.

For more information, please call Pamela Panagopoulos at u&u on 0414 893 ***, quoting reference number 34740. Alternatively, to apply please click the apply button.

Please submit your resume in Word format only.

Embark on a rewarding career with a company committed to making a difference in patients' lives globally.